New Pembrolizumab Indications Approved for Triple-Negative Breast Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) for patients with high-risk early-stage triple-negative breast cancer (TNBC) as neoadjuvant treatment in combination with chemotherapy and as single-agent adjuvant treatment following surgery. In addition, the FDA has confirmed the November 2020 accelerated approval of pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC with a programmed death ligand 1 (PD-L1) combined ...
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Sacituzumab Govitecan Granted Regular Approval for Triple-Negative Breast Cancer

The FDA has granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who previously have been treated with two or more systemic therapies, at least one of them for metastatic disease. Previously, the FDA had granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the ASCENT study (NCT0257445...
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Breast Cancer Metastases and Survival Outcomes: Wenbin Zhou, MD, PhD

Approximately 3%–8% of patients with newly diagnosed breast cancer have synchronous distant metastases, which are associated with a poor prognosis. Because therapeutic strategies are guided by the status of lymph node metastases, accurate assessment is necessary in order to select the appropriate treatment for different patients. In a study recently published in JAMA Network Open, a team of investigators found that patients with distant metastases experienced significantly worse survival compare...
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Addressing Gaps in Knowledge of Best Practices in Metastatic Triple-Negative Breast Cancer

Of all women diagnosed with cancer in the United States, 30% have breast cancer, which is the second-leading cause of cancer death in this group. Many women have benefitted from regular screening as well as earlier and improved treatment; however, 6% of women present with metastatic disease, and 30% with no initial lymph node involvement will develop metastatic disease. Women with metastatic breast cancer have a poorer prognosis than the overall population of breast cancer patients, and research...
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Racial Disparities Prevalent in Breast Cancer Recurrence Score and Mortality

Among patients with estrogen receptor (ER)-positive breast cancer, Black women are more likely to have a high-risk recurrence score, and those with axillary node–negative tumors have increased breast cancer–specific mortality within each risk category, according to a study now published in JAMA Oncology. In addition, the 21-gene Oncotype DX Breast Recurrence Score has less prognostic value for Black women. "The most commonly ordered genomic assay for obtaining prognostic information on the risk ...
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